Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

The test substance was evaluated by a range of non-testing approach utilising both the grouping capabilities within the OECD Toolbox as well as TIMES, an expert system. A read-across prediction was derived on Ames data both with and without metabolic activation. A prediction was also derived based on overall Ames result outcomes. Finally predictions were derived using TIMES with and without metabolic activation. On the basis of these 5 predictions, the results were consistent demonstrating that the test substance was negative for Ames. The absence of alerting groups for the test substance was effectively confirmed by the QSAR and read-across predictions derived.


Short description of key information:
The test substance is expected to be negative for genotoxicity in bacterial cells and did not produce tumours in a carcinogenicity study in rats.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The test substance is expected to be negative for genotoxicity in bacterial cells and did not produce tumours in a carcinogenicity study in rats. Therefore, no classification is required for genetic toxicity according to EU Directive 67/548/EEC and EU Classification and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.